Shape regulatory strategies, oversee registrations, and ensure compliance in a dynamic team. Join the team as Regional Regulatory Affairs Lead for a straightforward yet impactful career where you\xe2\x80\x99ll contribute to regulatory success and be a key part of multinational projects. If you\xe2\x80\x99re ready to lead and make a difference, explore this opportunity with us.

The Regional Regulatory Affairs Lead will be based in Dubai, UAE.

At DNA Recruitment, we carefully review all applications and aim to contact every suitable candidate within max. 5 working days. If you don\xe2\x80\x99t hear from us, please consider your application unsuccessful on this occasion.

Responsibilities

• The Regional Regulatory Affairs Lead will set a proper Regulatory Affairs strategy for the Middle East based on global & local business priorities.
• Accelerating already & planned new registrations.
• Leads an up-to-date Regulatory Affairs status for already registered products through timely submission of renewals and life cycle maintenance updates.
• Leads Regulatory intelligence: Make sure all relevant stakeholders are updated on the latest regulations.
• Make sure the scientific office license both establishment and promotion is up to date and in full compliance with local regulations.
• Serves as a consultant to managers. Manage regulatory activities relating to a specific portfolio of products/projects.
• Understands all aspects and phases of role-based activities (e.g.: the submission process across the product lifecycle continuum, including management of submission content/format to ensure high-quality submissions that facilitate review/approval by Regulatory Authorities.
• Ownership/Life cycle of Regulatory systems, trackers, and databases.
• Stewardship of Company position/impact of new/changing regulations, guidance, and standards.)
• Identify & prioritize key areas of regulatory risk.
• Initiate and develop role-based complex regulatory activities.
• Coordinate responses to complex questions from cross-functional areas promptly.
• Provide guidance to Compile and submit, promptly, regulatory documents according to regulatory requirements.
• Prepare SOPs to reflect specific local requirements.
• Responsible for updating and maintenance of role-based activities.
• Lead or represent Regulatory Affairs in project teams.
• Provide guidance and coaching for areas of responsibility to lower-level team members.

Qualifications and skills

• Min. 7 years of experience in regulatory affairs
• Bachelor\'s Degree in pharmaceuticals
• Proven expertise in Microsoft Office Suite including Word, PowerPoint, and Excel
• Good written and verbal communication skills and interpersonal relationship skills
• Strict attention to details
• Experience in a multinational organization would be an advantage

DNA consultant in charge of this requisition:

Tomasz Skrzypczak

CEEMEA Research Consultant

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